MAUDE Adverse Event Report: DEFIBTECH, L.L.C. LIFELINE; AUTOMATED CHEST COMPRESSOR

Model Number	RMU-1000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that when the rmu-1000 was turned on, there was an alarm light a warning sound and would not function.They reported that this did not occur during patient use.
Additional Manufacturer Narrative
Although requested, the device associated with this complaint has not been returned and the cause of the complaint is not known.Should additional information become available a follow-up mdr shall be submitted.
Additional Manufacturer Narrative
Analysis of the device logs identified that the unit was manufactured in 2019 and had performed a total of (b)(4) compressions.The logs documented intermittent motor-related fault conditions, including "motor didn't move in time" and "stroke depth not within specifications." functional testing confirmed that the device was capable of performing compressions; however, abnormal binding noise was observed during operation.Internal inspection identified damage to the motor connector on the motor control board which did not affect device operation.The exact root cause of the intermittent motor performance degradation could not be conclusively determined based on the available evidence.

• Brand Name: LIFELINE
• Common Device Name: AUTOMATED CHEST COMPRESSOR
• Manufacturer (Section D): DEFIBTECH, L.L.C.; 741 boston post rd.; suite 201; guilford CT 06437
• Manufacturer (Section G): DEFIBTECH, L.L.C.; 14 commercial st.; branford CT
• Manufacturer Contact: ian white ; 741 boston post road; suite 201; guilford, CT 06437 ; 2034536654
• MDR Report Key: 18717621
• Report Number: 3003521780-2024-00035
• Device Sequence Number: 17954025
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K141809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: RMU-1000
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown